Senior Executive - ITQA / Assistant Manager -ITQA

Job Description

Roles and Responsibilities To participate and prepare/ review Computer System Validation and IT-QMS documentation To implement automation at site in coordination with IT, CSV, and user departments To implement software at site i.e. Labware LIMS, SAP, e-QMS, e-DMS, e-LMS, Minitab, e-BMR, Lab-solution, Empower etc. To perform / participate in qualification / periodic qualifications of software at site To prepare compliance documents preparation against observations related to computer systems To participate / perform self-inspections / internal audits at site To prepare SOPs in Quality Assurance Department To involve in Regulatory audits/customer audits for the compliance of Software & IT systems at site. To participate in qualifications of IPC/ SCADA, PLC, HMI system based equipment. To participate in qualifications/calibration of system connected / standalone instruments in laboratory. To perform GAP assessment of computerized system with respect to regulatory and current requirements in GMP To perform and review Data Backup, Verification and Restoration in GxP systems. To perform / review Preventive Maintenance of GxP system software. Skills & Knowledge Required in Candidate Sound knowledge in automation / Software implementation in the pharmaceutical industry Management of GxP automation activities and compliance at site. Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines & GAMP guidelines Well-versed with EU Annex 11 / 21 CFT Part 11 guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any in software implemented at site Preference if any The candidate is required to be present at the site by JULY 2025.